Mdoloris ANI V1 User manual

Continouous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.10 –29 SEP 2021
Analgesia Nociception Index
ANI Monitor V1
User manual
Software version 1.1.4.0
(CE mark first approved on April 2012)
MDOLORIS MEDICAL SYSTEMS SAS
Biocentre Fleming
Bâtiment C Epi de Soil
270 rue Salvador Allende
59120 LOOS (France)
Tel: [phone] - Fax: [phone]
www.mdoloris.com

ANI Monitor V1 - Continouous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.10 –29 SEP 2021
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©Mdoloris Medical Systems. All rights reserved. Copying or other
reproduction of this document is prohibited without prior written
consent of Mdoloris Medical Systems.
ANI is a registered trademark.
Important information about using continuous analgesia
monitoring system:
The Mdoloris Medical Systems’ continuous analgesia monitoring
system is intended for use in a medical environment and under the
direct supervision of a licensed healthcare practitioner or by
personnel specifically trained for its use. The continuous analgesia
monitoring system is intended for use on adult and pediatric
patients, providing patient care by monitoring the parasympathetic
nervous tones activity by data acquisition of ECG signals.
The continuous analgesia monitoring system, and all its associated
parameters, may be used as an aid in monitoring the effects of
certain analgesic agents.
ANI Monitor V1 is a complex monitoring technology intended for
use as an adjunct to clinical judgment. Clinical judgment should
always be used when interpreting the ANI index in conjunction with
other available clinical signs. Reliance on ANI alone for interpreting
analgesic management is not recommended. As with any monitored
parameter, artifacts and poor signal quality may lead to
inappropriate ANI values. Potential artifacts may be caused by high
impedance of ECG source system, muscle activity or rigidity,
patient motion, improper sensor placement or electrical
interference.
ANI is a protected trademark.

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Table of contents
1 Safety precautions .............................................................................................................. 5
1.1 Warnings...................................................................................................................... 5
1.2 Cautions..................................................................................................................... 10
1.3 Notes.......................................................................................................................... 12
1.4 Key to Symbols ......................................................................................................... 12
2ANI monitor presentation.............................................................................................. 13
3ANI monitor installation ................................................................................................ 14
3.1 Clamping support ...................................................................................................... 14
3.2 Skin electrodes...............................................................................................................
3.3 ANI monitor connexion............................................................................................. 17
3.4 Battery ....................................................................................................................... 18
4Beginning the ANI monitoring ......................................................................................19
5ANI computing process .................................................................................................. 22
5.1 ECG Capture.............................................................................................................. 22
5.2 Respiratory Pattern .................................................................................................... 22
5.3 ANI Index.................................................................................................................. 23
5.4 Navigation panel........................................................................................................ 24
6ANI monitor setup .......................................................................................................... 25
6.1 Threshold................................................................................................................... 25
6.2 Events insert .............................................................................................................. 28
6.3 Expert mode and Energy index ................................................................................. 29
7Operating the ANI monitor............................................................................................ 32
7.1 Quit Patient................................................................................................................ 32
7.2 Demo ......................................................................................................................... 33
7.3 New patient................................................................................................................ 33
7.4 Maintenance............................................................................................................... 33
7.5 Delete patients data.................................................................................................... 34
7.6 Screen shot................................................................................................................. 35
7.7 Export Data................................................................................................................ 35
7.8 Update of events........................................................................................................ 37
7.9 Date and time settings................................................................................................ 38
7.10 Update monitor.......................................................................................................... 38
7.11 Shutting down the ANI monitor................................................................................ 41
8Troubleshooting .............................................................................................................. 41
9Monitor disposal.............................................................................................................. 42
10 Environnement................................................................................................................ 43
10.1 Shipping and Storage Environnement....................................................................... 43
10.2 Operating Environnement.......................................................................................... 43
10.3 Power Requirements and System Grounding............................................................ 44
11 Care, cleaning and maintenance.................................................................................... 44

ANI Monitor V1 - Continouous analgesia monitoring system
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11.1 Care and Cleaning ....................................................................................................... 44
11.2 Maintenance ................................................................................................................. 45
11.3 Leakage Current ........................................................................................................... 46
12 Specifications, warranty and software license agreement........................................... 46
12.1 Specifications ............................................................................................................... 46
12.2 Warranty.................................................................................................................... 47
12.3 Software License Agreement..................................................................................... 49

ANI Monitor V1 - Continouous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.10 –29 SEP 2021
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1 Safety precautions
INTRODUCTION:
Caution: carefully read this entire manual before using the monitor in a clinical setting.
WARNINGS, CAUTIONS AND NOTES
The terms warning, caution, and note have specific meanings in this manual.
•A WARNING advises against certain actions or situations that could result in physical
injury or death.
•A CAUTION advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure, although personal injury is
unlikely.
•A NOTE provides useful information regarding a function or procedure.
KEY TO SYMBOLS
A key to the symbols that may appear on the ANI Monitor V1 appears at the end of this
section.
1.1 Warnings
LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL
ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED.
PROTECTION AGAINST HEART DEFIBRILLATION SHOCK DEPENDS ON THE
APPROPRIATE CABLE USE.
EXPLOSION HAZARD: DO NOT USE THE ANI Monitor V1 IN A FLAMMABLE
ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE ANESTHETICS
MAY OCCUR.

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NEITHER THE MONITOR NOR THE SKIN ELECTRODES ARE DESIGNED FOR
USE IN THE MRI ENVIRONMENT.
THIS ANI Monitor V1 COULD NOT BE IN ANY CASE CONSIDERED AS AN ECG
MONITORING SYSTEM.
CONSIDERATIONS WHEN USING ELECTRO-CONVULSIVE THERAPY (ECT)
EQUIPMENT DURING THE ANI MONITORING: place ECT electrodes as far away as
possible from the sensors to minimize the effect of interference. Some ECT equipment may
interfere with the proper functioning of the ANI Monitor V1. Check for compatibility of
equipment during patient setup.
ONLY USE THE POWER CORD SUPPLIED BY THE MANUFACTURER. NEVER
ADAPT THE PLUG FROM THE MONITOR TO FIT A NON-STANDARD OUTLET.
IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND IS IN
DOUBT, THE ANI Monitor V1 SHOULD NOT BE USED.
BE SURE THE MONITOR IS INSTALLED SECURELY TO AVOID PERSONAL OR
PATIENT INJURY.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE
COMPUTER), THE LEAKAGE SYSTEM CURRENT MUST BE CHECKED AND MUST
BE LESS THAN THE IEC 60601-1-1 LIMIT.

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THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE
MANUFACTURERS REQUIREMENTS MAY INFLUENCE THE SAFETY OF THE
RESULTING SYSTEM. CONSIDERATION RELATING TO THE CHOICE OF
EQUIPMENT SHALL INCLUDE:
- USE OF THE ACCESSORY IN THE PATIENT VICINITY AND OR SURGERY
VICINITY
- EVIDENCE THAT THE SAFETY CERTIFICATION « CE » OF THE ACCESSORY AS
BEEN PERFORMED IN ACCORDANCE TO THE HARMONIZED STANDARD (IEC
60601-1 AND/OR IEC 60601-1-1) APPLIED TO THE ANI Monitor V1.
BE SURE NOT TO PLACE THE INTERFACE EQUIPMENT DIRECTLY IN
PROLONGED CONTACT WITH SKIN TO AVOID PERSONAL OR PATIENT INJURY
DUE TO HIGH SURFACE TEMPERATURE.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSORS AND CONNECTORS
SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT
INTERFACE CABLE MUST BE CAREFULLY PLACED AND SECURED.
ENSURE PROPER CONTACT OF THE ELECTROSURGERY RETURN ELECTRODE
TO AVOID POSSIBLE BURNS ON THE PATIENT VIA ANI ELECTRODES.
THE CHARACTERISTICS OF ANI Monitor V1 EMISSIONS ALLOW IT TO BE USED
IN INDUSTRIAL AREAS AND HOSPITALS (CISPR 11 CLASS A). WHEN USED IN
RESIDENTIAL ENVIRONMENTS (FOR WHICH CISPR 11 CLASS B IS REQUIRED),
ANI Monitor V1 CANNOT GUARANTEE PROVISION OF ADEQUATE PROTECTION

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OF RADIO FREQUENCY COMMUNICATION. THE USER MIGHT NEED TO
PERFORM CORRECTIVE ACTIONS, SUCH AS REIMPLANTATION OR
REORIENTATION OF THE ANI Monitor V1.
THE INTERFACE WIRE HAS TO BE CAREFULLY PLACED AND HELD DOWN TO
PREVENT ANY PATIENT STRANGULATION RISK.
DO NOT PLACE SKIN ELECTRODES BETWEEN DEFIBRILLATOR PADLLE WHEN
IT’S USED ON A PATIENT CONNECTED TO THE ANI Monitor V1.
USE AGAIN AN ARRAY ALREADY USED ON PREVIOUS PATIENT COULD LEAD
RISK OF CROSS-CONTAMINATION.
IF THE PATIENT DEVELOPS A CUTANEOUS RASH OR OTHERS UNUSUAL
SYMPTOMS, REMOVE THE ARRAY. IT IS IMPORTANT TO ADAPT A PARTICULAR
CARE TO PATIENTS SUFFERING FROM DERMATOLOGICAL PROBLEMS.
NEVER PUT ELECTRODES ON INJURIES.
ON ELECTRICAL SHOCK HAZARD :
-DO NOT ATTEMPT TO DISCONNECT THE POWER CORD WITH WET
HANDS.
-DO NOT REMOVE MONITOR COVERS DURING OPERATION OR WHILE
POWER IS CONNECTED TO MONITOR.

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-THE MANUFACTURER'S INSPECTION OF THIS APPARATUS VERIFIED
THAT THE GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY
CURRENT WERE LESS THAN THE SPECIFIED LIMITS ESTABLISHED BY
THE APPLICABLE SAFETY STANDARDS. AS A MATTER OF SAFE
PRACTICE, THE INSTITUTION SHOULD ALSO CONDUCT TESTS TO
VERIFY THESE CURRENTS ESPECIALLY WHEN A QUALIFIED
BIOMEDICAL ENGINEERING TECHNICIAN PERIODICALLY OPENS THE
INSTRUMENT CASE.
-WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS
OCCURS, RE-TEST GROUND LEAKAGE CURRENT BEFORE FURTHER
USE.
UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT
WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS.
CONTAMINATED MATERIALS MUST BE PLACED IN A FACILY IN ACCORDANCE
WITH ALL APPLICABLE HYGIENE STANDARDS AND REGULATIONS.
DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND AMMONIA), AS
HAZARDOUS GASES MAY RESULT.
THE ANI Monitor V1 COMPLIES WITH ELECTROMAGNETIC COMPATIBILITY
REQUIREMENTS OF EN 60601-1-2. OPERATION OF THIS DEVICE MAY AFFECT
OR BE AFFECTED BY OTHER EQUIPMENT IN THE VICINITY DUE TO
ELECTROMAGNETIC INTERFERENCE (EMI). IF THIS OCCURS:
- INCREASE SEPARATION BETWEEN DEVICES
- CHANGE THE ORIENTATION OF DEVICE CABLING
- PLUG DEVICES INTO SEPARATE CIRCUIT OUTLET
OR PLEASE CONTACT YOUR MDOLORIS MEDICAL SYSTEMS REPRESENTATIVE.

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THE ANI Monitor V1 IN OPERATING SURGICAL ROOM MUST BE PLACED
OUTSIDE THE SAFETY CONE OF EXPLOSION RISK.
TO AVOID THE HAZARD OF BURNS BE SURE THE MONITOR IS INSTALLED
OUTSIDE THE SURGICAL SECURITY AREA AND AS FAR AS POSSIBLE FROM
LIQUID INGRESS TO PREVENT SYSTEM DAMAGE.
IF THE MONITOR SHOULD BE OPEN ANY MODIFICATIONS ARE ALLOWED TO
BE DONE.
1.2 Cautions
Read this entire manual carefully before using the monitor in a clinical setting.
Before starting, please ensure there are no USB devices (USB stick for example)
connected to the monitor.
Equipment should not be reachable by the patient.
ANI Monitor V1 should not be used adjacent or stacked with other equipment. If adjacent or
stacked use is necessary, the monitor should be observed to verify normal operation in the
configuration in which it will be used.
Patient and equipment should not be touched simultaneously by the doctor.
Unused monitor ports should not be connected with other devices.
Do not autoclave the monitor or the acquisition device. Autoclaving will seriously damage
both components.